# K991583: Neurosign 400, 4 Channel Motor Nerve Monitor

- Pathway: 510(k) (Special)
- Applicant: The Magstim Company, Ltd.
- Decided: May 19, 1999 after 12 days
- Product code: ETN (Stimulator, Nerve)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K923056 (1992). 2 ancestors in all.
44 later devices descend from it; 3 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964869: Neurosign 800, 8 Channel Motor Nerve Monitor, The Magstim Company, Ltd. (1997) Summary page 1.
- K923056: Neurosign Model 100, The Magstim Company, Ltd. (1992) Summary page 1.

## Most influential descendants
- K050325: Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar Probe (2005), 38 descendants of its own
- K062996: Disposable Monopolar and Bipolar Stimulator Probes (2007), 32 descendants of its own
- K090838: Stimulus/Dissection Instruments (2009), 19 descendants of its own
- K063729: Disposable Pedicle Screw Probe, Model 3603-00 (2007), 19 descendants of its own
- K103128: Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw Stimulator Probe, (2011), 17 descendants of its own

## Indications for use
To locate and identify cranial motor nerves during ENT and intra-cranial procedures.

Source page: https://510kreport.com/device/K991583
Methodology: https://510kreport.com/methodology